UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032595
Receipt number R000037167
Scientific Title The Use of Yoga for Lumbar Spine Post-Surgical Pain Management
Date of disclosure of the study information 2018/10/18
Last modified on 2018/05/15 06:22:39

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Basic information

Public title

The Use of Yoga for Lumbar Spine Post-Surgical Pain Management

Acronym

Yoga following lumbar spine surgery

Scientific Title

The Use of Yoga for Lumbar Spine Post-Surgical Pain Management

Scientific Title:Acronym

Yoga following lumbar spine surgery

Region

North America


Condition

Condition

Post lumbar spine surgery

Classification by specialty

Surgery in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to is to test the feasibility of a tailored yoga program offered for acute pain management during and immediately after an inpatient hospital stay in a small two armed stratified randomized controlled cross over trial. Acute pain during hospital stay is a major challenge to manage following surgical procedures.

Basic objectives2

Others

Basic objectives -Others

Specific aims are to:
Aim 1. Determine feasibility of tolerance and use of a modified yoga intervention implemented during hospital stay to patients following lumbar spine surgery.
Aim 2. Determine the effectiveness of modified yoga intervention implemented during hospital stay to improve physical function and decrease pain and anxiety post lumbar spine surgery compared to usual care.
Aim 3. Determine the feasibility of an 8 week home-based modified yoga program specific for patients who have had lumbar spinal surgery immediately following hospital discharge

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase



Assessment

Primary outcomes

NIH pain assessment and history,
Beck anxiety inventory
Timed up and go test

Key secondary outcomes

Demographics,
Medications,
Pittsburgh sleep quality index
Pain catastrophizing scale
Perceived stress scale -10


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Yoga

Interventions/Control_2

Control

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

40 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Inclusion criteria:
Adults between 40 and 80 yrs old scheduled for lumbar spine surgery (laminectomy with or without fusion)

Key exclusion criteria

Exclusion criteria

1) cancer related pain, 2) cauda equina syndrome, 3) spinal tumor, 4) regular practice of Yoga

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Neena Sharma

Organization

The University of Kansas Medical Center

Division name

Department of Physical Therapy

Zip code


Address

3901 Rainbow Blvd/ MS 2002, Kansas City, KS, 66160

TEL

913-588-4566

Email

NSHARMA@kumc.edu


Public contact

Name of contact person

1st name
Middle name
Last name Kosaku Aoyagi

Organization

The University of Kansas Medical Center

Division name

Department of Physical Therapy

Zip code


Address

3901 Rainbow Blvd/ MS 2002, Kansas City, KS, 66160

TEL

913-588-4340

Homepage URL

http://www.kumc.edu/school-of-health-professions/research/clinical-orthopedic-rehabilitation-and-res

Email

kaoyagi@kumc.edu


Sponsor or person

Institute

N/A

Institute

Department

Personal name



Funding Source

Organization

N/A

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 10 Month 18 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 07 Month 11 Day

Date of IRB


Anticipated trial start date

2016 Year 10 Month 11 Day

Last follow-up date

2017 Year 11 Month 11 Day

Date of closure to data entry

2017 Year 12 Month 31 Day

Date trial data considered complete

2017 Year 12 Month 31 Day

Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 05 Month 15 Day

Last modified on

2018 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037167


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name